SILVER SPRING, Md., July 29, 2014 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced its financial results for the second quarter ended June 30, 2014.
"Our continued growth shows that our medicines are reaching increasing numbers of patients suffering from pulmonary arterial hypertension (PAH)," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The commercial launch this quarter of our extended-release tablet called Orenitram® harkens an opportunity to bring prostacyclin-based medicine to more PAH patients in the U.S. than ever before, by providing a less-invasive route of administration than our prostacyclin infusion therapy called Remodulin®."
Total revenues for the quarter ended June 30, 2014 were $322.8 million, up from $280.6 million for the quarter ended June 30, 2013. Net income for the quarter ended June 30, 2014 was $111.9 million or $2.35 per basic share, compared to $79.9 million or $1.60 per basic share for the same quarter in 2013. Gross margin from sales was $282.6 million for the quarter ended June 30, 2014, compared to $245.2 million for the same quarter last year. Non-GAAP earnings(1) for the quarter ended June 30, 2014 were $122.4 million, compared to $125.1 million for the same quarter in 2013.(1)
See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below.Financial Results for the Three Months Ended June 30, 2014 Revenues
The table below summarizes the components of net revenues (dollars in thousands):Three Months Ended
1,4733,111(52.7)%Total net revenues
280,60615.0%Revenues for the quarter ended June 30, 2014 increased by $42.2 million, compared to the same quarter in 2013. The growth in product revenues reflects the continuing increase in the number of patients being treated with our products and the launch of Orenitram.
The table below summarizes research and development expense by major project and non-project components (dollars in thousands):Three Months Ended
Change20142013Project and non-project component:Cardiopulmonary
28,537(0.9)%Share-based compensation expense
10,42111,922(12.6)%Total research and development expense
54,617(27.2)%Share-based compensation. The decrease in share-based compensation of $13.1 million for the quarter ended June 30, 2014, compared to the same quarter in 2013, resulted primarily from the decline in the price of our common stock.
The table below summarizes selling, general and administrative expense by major categories (dollars in thousands):Three Months Ended
Change20142013Category:General and administrative
35,44535.1%Sales and marketing
22,04617,34427.1%Share-based compensation (benefit) expense
(1,904)18,576(110.2)%Total selling, general and administrative expense
71,365(4.7)%General and administrative. The increase in general and administrative expense of $12.4 million for the quarter ended June 30, 2014, compared to the same quarter in 2013, was driven by increases in professional and consulting fees, salaries and related expenses and grants to non-affiliated, not-for-profit organizations.
Sales and marketing. The increase in sales and marketing expense of $4.7 million for the three months ended June 30, 2014, compared to the same three-month period in 2013, was the result of expenses incurred with the commercial launch of Orenitram and an increase in salaries and related expenses due to the growth of our sales operations.
Share-based compensation. The decrease in share-based compensation of $20.5 million for the quarter ended June 30, 2014, compared to the same quarter in 2013, resulted from the decline in the price of our common stock.
The provision for income taxes was $61.2 million for the quarter ended June 30, 2014, compared to $38.7 million for the same quarter in 2013. Our estimated annual effective tax rates were 35 percent and 33 percent as of June 30, 2014 and June 30, 2013, respectively. Our 2014 estimated annual effective tax rate increased as of June 30, 2014 primarily due to a reduction in the amount of business tax credits we expect to generate during 2014 versus our estimate at June 30, 2013.
Non-GAAP EarningsNon-GAAP earnings is defined as net income, adjusted for the following charges, as applicable: (1) interest; (2) license fees; (3) depreciation and amortization; (4) impairment charges; and (5) share-based compensation (stock option, share tracking award and employee stock purchase plan expense).
A reconciliation of net income to non-GAAP earnings is presented below (in thousands, except per share data):Three Months Ended
June 30,20142013Net income, as reported
79,864Adjust for the following charges:Interest expense
——Depreciation and amortization
——Share-based compensation (benefit) expense
125,050Non-GAAP earnings per share:Basic
2.38Weighted average number of common shares outstanding: Basic
53,25252,648Conference CallWe will host a half-hour teleconference on Tuesday, July 29, 2014, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406 and using access code 67533397.
This teleconference is also being webcast and can be accessed via our website at http://ir.unither.com/events.cfm.
About Orenitram (treprostinil) Extended-Release TabletsIndication
Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%).
When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this. Orenitram is probably most useful to replace subcutaneous, intravenous, or inhaled treprostinil, but this use has not been studied.
Important Safety Information for Orenitram
For Full Prescribing Information for Orenitram, visit www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).About Remodulin (treprostinil) InjectionIndication
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.
In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
Important Safety Information for Remodulin
For Full Prescribing Information for Remodulin, visit http://www.remodulin.com or call 1-877-UNITHER (1-877-864-8437).About United TherapeuticsUnited Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
Non-GAAP Financial InformationThis press release contains a financial measure, non-GAAP earnings, that does not comply with United States generally accepted accounting principles (GAAP). This measure supplements our financial results prepared in accordance with GAAP as reported below.
We use non-GAAP earnings to assist us in: (1) planning, including the preparation of our annual operating budget; (2) allocating resources in an effort to enhance the financial performance of our business; (3) evaluating the effectiveness of our operational strategies; and (4) assessing our capacity to fund capital expenditures and expand our business. We believe this non-GAAP financial measure improves investors' understanding of our financial results by excluding certain expenses that we do not consider when evaluating and comparing the performance of our core operations and making operating decisions. However, there are limitations in the use of this non-GAAP financial measure in that it excludes certain operating expenses that are recurring in nature. In addition, our calculation of this non-GAAP financial measure may differ from the methodology used by other companies. The presentation of this non-GAAP financial measure should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP. A reconciliation of net income, the most directly comparable GAAP financial measure, to non-GAAP earnings can be found in the table above under the heading, Non-GAAP Earnings.
Forward-looking StatementsStatements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our expectations about continued increases in the number of patients using our therapies and our expectations regarding Orenitram's potential. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of the date of this press release, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g]
Orenitram, Remodulin and Tyvaso are registered trademarks of United Therapeutics Corporation.
Adcirca is a registered trademark of Eli Lilly and Company.
UNITED THERAPEUTICS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)Three Months Ended
June 30,Six Months Ended
June 30,2014201320142013(Unaudited)(Unaudited)Revenues:Net product sales
322,802280,606612,205525,742Operating expenses:Research and development
39,74254,61752,190105,047Selling, general and administrative
68,03171,36598,246142,721Cost of product sales
38,70932,32069,30961,633Total operating expenses
176,320122,304392,460216,341Other (expense) income:Interest income
349(134)802121Total other (expense) income, net
(3,287)(3,785)(6,211)(6,987)Income before income taxes
173,033118,519386,249209,354Income tax expense
142,189Net income per common share:Basic
2.71Weighted average number of common shares outstanding:Basic
53,25252,64854,94852,386SELECTED CONSOLIDATED BALANCE SHEET DATA
June 30, 2014
(Unaudited, in billions)Cash, cash equivalents and marketable securities (excluding restricted amounts)$
0.76Total assets1.95Total liabilities and temporary equity0.78Total stockholders' equity1.17
|SOURCE United Therapeutics Corporation|
Copyright©2014 PR Newswire.
All rights reserved